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ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix

Q

Qualitygds

#11
#11
Dan LaBelle said:
Hello hello,
Working for a Medical Device company that designs, manufactures, and distributes devices throughout the world, there are 4 key standards requirements that need to be compliant to as of today anyways. As an auditor, I must ensure that my organization is compliant to them and make sure that I am covering all applicable elements of each standard during each audit that I conduct.

My question is: does anyone know of or have an example of a Matrix that compares ISO 13485: 1996/2003, FDA QSR requirements, Canadian Medical Device Requirements (CMDR), and the Medical Device Directives (MDD) in one document. It would be a helpful tool and also proof to our external auditors that our internal audit system is covering all applicable requirements during internal audits.

I have attached my current matrix that doesn't include CMDR and MDD. I have been working on adding both these requirements but am having difficulties because of the semantic nature of how these requirements have been written. Another words, CMDR written by Canadians. MDD written by the European Union and they both have their own way of writing things in a long novel style.

Thanks, Look forward to hearing from you all.
Click to expand...
Hello,

I'm in a similar situation as Dan was, trying to put together a correlation matrix between the 4 (ISO 13485: 2003, FDA QSR, CMDR, and MDD) standards requirements and wanted to find out if anyone has an example to share. I got helps for the ISO 13485 and FDA QSR already but not for the CMDR and MDD. Hope to hear from everyone.

:thanx:
 
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R

rach14

#12
#12
This is a guidance doc from GHTF - specifically refers to adverse event reporting requirements for USA (FDA), EU, CAN, Australia, and Japan:

search: SG2/N6R3

...still may be helpful.

I have a question that is somewhat along these lines...we recently received certification for ISO 13485, MDD Annex II, and Part I of CMDR. (As just a little background, I only began working with this company at the beginning of the year. The last Regulatory Manager decided to change notified bodies before our certification expired - don't ask why.) We did have a license from Health Canada, but now we must re-apply. I'm still trying to learn the regulatory requirement specific to Canada. My question here regards labeling. (Ours is class III, by the way.) Section 21, part (d) refers to the control number - what is this?

Thanks for any help
 
C

CBAL08

#13
#13
The charts provided here are indeed very useful. Could someone help me to find out the list of all Essential procedures required for FDAs QSR ???
 
D

dennisburns

#14
#14
Hi,
I have just joined the forum and wandered if there were any updates to the discussion about cross references for the aforementioned Standards / Regulations between Europe / US & Canada Medical Device reguirements (ISO 13485)

A second question is that I have just been co-opted to a Dental Company who identify their product as Class I, how does this rate within these regulations and requirements?
Cheers
 
T

ts16949guy

#15
#15
DennisB said:
Hi,
I have just joined the forum and wandered if there were any updates to the discussion about cross references for the aforementioned Standards / Regulations between Europe / US & Canada Medical Device reguirements (ISO 13485)

A second question is that I have just been co-opted to a Dental Company who identify their product as Class I, how does this rate within these regulations and requirements?
Cheers
Click to expand...

Im looking for the exact same information.....Anyone have it?
 
M

MDQSA

#16
#16
You can purchase "Comparison Matrix: ISO 13485:2003 and Medical Devices Regulations" from BSI. I think it was about $50 (definitely less than $100) and it compares the 13485 clauses to 21 CFR 820, SOR/98-282 (CMDR), EU MDD & JPAL.
It's a good reference document, but don't take it as gospel. I did find a few omissions, so don't use it in place of the standards.
 
S

sim24kins

#18
#18
Can you please email me the table that you have, it is not posting on the forum. It would be greatly appreciated!
 
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